Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were enrolled in a total of 30 sites in the United States. The first participant was screened on 30 March 2009.

Last participant visit:

Primary endpoint analysis (Week 24): November 2009

Week 48 analysis: April 2010

Week 96 analysis: March 2011

End of study: September 2013

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

126 participants were screened; 71 were randomized (48 to the Stribild group and 23 to the Atripla group). All randomized participants received at least 1 dose of study medication and comprised the safety and intent-to-treat (ITT) analysis sets. No site enrolled more than 7% of participants.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Safety Analysis Set: participants were randomized and received at least 1 dose of study medication.

Reporting Groups

Description

Stribild

Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.

Atripla

Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.

The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24 [ Time Frame: Week 24 ]

Measure Type

Primary

Measure Title

The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24

Measure Description

The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 24 was summarized.

Time Frame

Week 24

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

ITT analysis set (all participants who were randomized into the study and received at least 1 dose of study drug). The missing = failure (M = F) analysis method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).

Reporting Groups

Description

Stribild

Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.

Atripla

Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.

Measured Values

Stribild

Atripla

Participants Analyzed [Units: Participants]

48

23

The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24 [Units: Percentage of participants]

89.6

87.0

Statistical Analysis 1 for The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24

Groups [1]

All groups

Non-Inferiority/Equivalence Test [2]

Yes

Difference in the response rates (%) [3]

2.8

95% Confidence Interval

-14.5 to 20.1

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

The null hypothesis was that the response rate (proportion of participants with HIV-1 RNA < 50 copies/mL at Week 24) in the Stribild group was at least 12% worse than the response rate in Atripla group; the alternative hypothesis was that the response rate in the Stribild group was less than 12% worse than that in the Atripla group.

[2]

Details of power calculation, definition of non-inferiority margin, and other key parameters:

A total sample size of 75 participants randomized in a 2:1 ratio had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA < 50 copies/mL at Week 24 if a response rate of 84% for both treatment groups and a noninferiority margin of 0.12 were assumed.

A total of 71 participants were enrolled in the study (4 fewer than planned).

The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48 [ Time Frame: Week 48 ]

Measure Type

Secondary

Measure Title

The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48

Measure Description

The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 48 was summarized.

Time Frame

Week 48

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

ITT analysis set; The missing = excluded (M = E) analysis method was used in which all missing data were excluded from the analysis.

Reporting Groups

Description

Stribild

Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.

Atripla

Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No statistical analysis provided for Change From Baseline in CD4 Cell Count at Week 48

6. Secondary:

The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL [ Time Frame: Baseline to Weeks 24 and 48 ]

Measure Type

Secondary

Measure Title

The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL

Measure Description

The percentage of participants with virologic success at Weeks 24 and 48 assessed using the FDA-defined snapshot analysis for an HIV-1 RNA cutoff of 50 copies/mL was summarized.

Time Frame

Baseline to Weeks 24 and 48

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

ITT analysis set

Reporting Groups

Description

Stribild

Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.

Atripla

Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.

Measured Values

Stribild

Atripla

Participants Analyzed [Units: Participants]

48

23

The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL [Units: Percentage of participants]

Virologic Success at Week 24

89.6

87.0

Virologic Success at Week 48

91.7

82.6

No statistical analysis provided for The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL